Table 7– Serious adverse effects in randomised latent tuberculosis (TB) infection treatment trials (reported after 1990) with a placebo/no treatment arm

Lead author [ref.]	Site (year)	Cases/number treated^#					RR (95% CI)^¶
Lead author [ref.]	Site (year)	H	HR	RZ(H)	R	Placebo	H	HR	RZ(H)	R
HIV-infected
Pape 98	Haiti (1993)	0/58⁺				0/60	0.0 (0.0–0.0)
Whalen 99	Uganda (1997)	3/536^§	13/556	26/462^ƒ		1/464	2.60 (0.27–24.88)	10.85 (1.42–82.62)	26.11 (3.56–191.6)
Whalen 99 (anergy)	Uganda (1997)	0/395^§				0/323	0.0 (0.0–0.0)
Gordin 100	USA (1997)	24/260^§				24/257	0.99 (0.58–1.69)
Hawken 101	Kenya (1997)	11/342^§				5/342	2.20 (0.77–6.26)
Mwinga 102	Zambia (1998)	12/352^##		14/351^¶¶		3/350	3.98 (1.13–13.97)		4.65 (1.35–6.05)
Rivero 104	Spain (2003)	6/83^§	15/82	13/77⁺⁺		0/77	12.07 (0.69–210.76)	29.13 (1.77–478.67)	27.00 (1.63–446.3)
Non-HIV infected
Girling 73	Hong Kong (1992)	13/173^§	11/167		7/172	5/167	2.51 (0.89–7.04)	2.2 (0.76–6.33)		1.36 (0.43–4.28)
John 74	India (1994)	38/92⁺				33/92	1.15 (0.72–1.84)

RR: relative risk; H: isoniazid for 6–12 months; HR: isoniazid plus rifampicin daily for 3 months; RZ(H): rifampicin plus pyrazinamide or rifampicin plus pyrazinamide plus isoniazid for 2–3 months; R: rifampicin daily for 3 months. ^#: adverse events leading to termination of treatment; ^¶: isoniazid versus regimen; ⁺: isoniazid daily for 12 months; ^§: isoniazid daily for 6 months;^ƒ: isoniazid plus rifampicin plus pyrazinamide daily for 3 months; ^##: isoniazid twice weekly for 6 months;^¶¶: rifampicin plus pyrazinamide twice weekly for 3 months; ⁺⁺: rifampicin plus pyrazinamide daily for 2 months.